An Observational Study on the Safety Profile of MabThera/Rituxan (Rituximab) in Combination With Chemotherapy in Patients With B Cell-lineage Chronic Lymphocytic Leukaemia (MABERYC)

Lymphocytic Leukemia, Chronic Clinical Trial

Official title:

A Multicentre, Observational, Prospective Study to Assess the Safety Profile of Rituximab in Combination With Chemotherapy in Patients With B Cell-lineage Chronic Lymphocytic Leukaemia (B-CLL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224093
• Other study ID #: ML25372
• Status: Completed
• Phase: N/A
• First received: October 18, 2010
• Last updated: November 1, 2016
• Start date: October 2010
• Est. completion date: February 2014

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Observational

Clinical Trial Summary

This prospective observational study will evaluate the safety of MabThera/Rituxan (rituximab) in combination with chemotherapy in patients with previously untreated or relapsed/refractory B cell-lineage chronic lymphocytic leukaemia. Data will be collected from each patient for 6-12 months, depending on the prescribed chemotherapy regimen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• B cell-lineage chronic lymphocytic leukaemia (B-CLL)

• Prescribed with MabThera/Rituxan in combination with chemotherapy according to the approved SMPC

• Informed consent to data collection

Exclusion Criteria:

• Treatment with any marketed or non-marketed drug substance or experimental therapy within 4 weeks prior to first dose of study drug or participation in a clinical trial within 30 days prior to entering this study

• Any other tumour disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphocytic Leukemia, Chronic

Intervention

Drug:
• Chemotherapy
as prescribed
• rituximab [MabThera/Rituxan]
as prescribed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety profile of MabThera/Rituxan in combination with chemotherapy in unselected CLL patients		3 years	No
Secondary	Efficacy (Response rate, duration of response, progression-free survival)		3 years	No
Secondary	Chronic lymphocytic leukaemia (CLL) Comorboid Scale		3 years	No
Secondary	Quality-adjusted survival analysis (Q-TWIST methodology)		3 years	No